Primary Surgical Prevention of Breast Cancer-related Lymphedema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorGangnam Severance Hospital
About this trial
Lymphedema refers to edema caused by insufficient drainage of interstitial fluid through the lymphatic circulation system. It occurs mainly in the upper and lower extremities and causes chronic inflammation, and finally fibrous adipose tissue is replaced. In this study, the'LYMPHA' (Lymphatic microsurgical preventing healing approach) procedure, which connects lymphatic vessels drained from the arm to the side branches of the axillary vein, contributes to the prevention of lymphedema in patients undergoing axillary lymph node dissection for breast cancer. Investigator aim to help patients' quality of life by prospectively analyzing the effects and applying them to clinical practice, reducing the incidence of lymphedema.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age over 19 years old
Patients who are expected to undergo surgery under the diagnosis of breast cancer, and are determined to undergo axillary lymph node dissection before surgery.
Disqualifiers
Patients with vascular and lymph-related diseases
Patients with a history of surgical treatment or trauma to both arms and axillary
Patients with a history of receiving radiation treatment in both arms, chest, and axilla
Patients with confirmed systemic metastasis with stage 4 breast cancer
Trial design
Design model
Parallel
Treatments tested in this trial
LYMPHA
Procedure/SurgeryAxillary reverse mapping is performed before surgery, axillary lymph node resection is performed, and 'LYMPHA' (Lymphatic microsurgical preventing healing approach) is performed, and the surgery is terminated. Subsequently, the occurrence of lymphedema is followed up.
control
Procedure/SurgeryIn the control group, axillary lymph node resection is performed and the surgery is terminated without additional procedures. Subsequently, the occurrence of lymphedema is followed up.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: LYMPHAExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of lymphedema
To compare the incidence of lymphedema assessed by UEL index and lymphoscintigraphy at 2 years after the surgery.
Time frame
2 years after surgerySecondary outcomes
1
UEL index
To compare the UEL index
Time frame
2 years after surgery2
Changes in Lymphoscintigraphy
To compare the changes in lymphoscintigraphy presented by the change of transport index (TI)
Time frame
2 years after surgery3
Incidence of lymphedema
To compare the incidence of lymphedema assessed by UEL index and lymphoscintigraphy at 5 years after the surgery.
Time frame
5 years after surgery4
5-year recurrence rate
To compare the recurrence rate
Time frame
5 years after surgerySponsors and contacts
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Source ClinicalTrials.gov